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Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts

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ClinicalTrials.gov Identifier: NCT03258112
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Abo Elhassan Abdel_Rady, Assiut University

Brief Summary:

Ventricular arrhythmias arising from cardiac outflow tract affect quality of life and can cause decrease in left ventricular ejection fraction.

Drugs used for treating those arrhytmias may be ineffective or may have side effects.

Radiofrequency catheter ablation can be used safely for treatment of outflow tract arrhythmias.

There are different sites where those ventricular arrhythmias may originates, each site has different electrocardiographic characteristics, different procedural success rates and challenges in localization and ablation.


Condition or disease Intervention/treatment Phase
Ventricular Arrythmia Procedure: Radiofrequency cardiac catheter ablation Not Applicable

Detailed Description:

The right and left ventricular outflow tracts (RVOT/LVOT) are the most common sites of origin for idiopathic ventricular tachycardia (VT) and premature ventricular contractions (PVCs) in patients without structural heart disease.1

Frequent PVCs was associated with PVC-induced cardiomyopathy, and radiofrequency (RF) catheter ablation of frequent PVCs was associated with improvement of left ventricular ejection fraction (LVEF).2

The most common underlying pathophysiological mechanism was identified to be triggered activity and RF catheter ablation treatment is highly effective with low complication rates.1,3 Drug therapy has limited effectiveness (in case β-blockers and calcium-channel blockers) or drug-related side effects ( in case of flecainide, propafenone and amiodarone).4

RF catheter ablation is recommended in cases of high PVC burden associated with decreased LV ejection fraction (LVEF) or in highly symptomatic patients despite optimal drug therapy.3

Although the RVOT is the most common site (about 70-80% of cases) for idiopathic VAs1,5, only few studies have reported on the prevalence and RF catheter ablation of ventricular arrhythmias (VAs) arising from the pulmonary artery (21-46% among the RVOT VAs)6 and even less prevalence is reported in VAs arising from the pulmonary sinus cusps (11%).7

Compared with VAs originating from the RVOT, ablation of LVOT-VAs is more complex and reported to be 12-45% of all idiopathic VAs.8-11 The success rate of ablation of LVOT-VA sites was previously reported to be lower (55-60%) without using antegrade/transseptal approaches.12,4 Rarely, it requires epicardial ablation via the GCV/AIV or subxiphoid puncture.13,14

There are some cases in which RF catheter ablation cannot successfully be performed from either LVOT or RVOT. In such cases the VAs may originate from the LV-summit which is the most common site of idiopathic epicardial VAs from the LVOT region.13

Although most idiopathic VAs originating from the cardiac OTs are suitable targets for endocardial RF catheter ablation, a small percentage of failures in these patients may be because of an inaccessible site of origin from epicardial or intramural septal locations.15The identification, mapping and RF catheter ablation of these idiopathic VAs may be challenging for the electrophysiologist and need special consideration.16


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Catheter Ablation of Idiopathic Ventricular Arrhythmias Arising From Cardiac Outflow Tracts
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
catheter ablation
all patients indicated for catheter ablation of RVOT or LVOT ventricular arrhythmia are included in one arm for electrophysiological diagnosis of the origin of arrhythmia then for radiofrequency catheter ablation
Procedure: Radiofrequency cardiac catheter ablation
procedure used for ablation of ventricular arrhythmia using catheters introduced to target sites percutaneously through venous or arterial systems using radiofrequency power



Primary Outcome Measures :
  1. procedural success [ Time Frame: 24 hours after the procedure ]
    success of the procedure in ablation of ventricular arrhythmia with termination of ventricular arrhythmia, absence of induction of arrhythmia and 24 hours electrocardiographic monitoring after the procedure documenting absence of ventricular arrhythmia


Secondary Outcome Measures :
  1. Recurrence of ventricular arrhythmia after three months [ Time Frame: Three months ]
    Appearance of symptoms of palpitation and documentation of recurrence of same type of arrhythmia with prolonged electrocardiographic monitoring in case of symptoms



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with idiopathic RVOT/LVOT ventricular arrhythmias in cases of Frequent (PVCs =10.000/24hours), NSVT, or VT Symptomatic, Associated with LV dysfunction (no explained with any cause other than VAs) or Resistance, patient intolerance or patient refusal of drug therapy

Exclusion Criteria:

  • Presence of coronary artery disease, valvular heart disease or any other underlying causes
  • arrhythmia not originating from cardiac outflow tracts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258112


Contacts
Contact: Mohamed Abo Elhassan abdel-Rady 00201009078977 mabolhassan10@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Mohamed Abo Elhassan Abdel-Rady Assiut University

Publications of Results:

Other Publications:
Latchamsetty R, Yokokawa M, Morady F, Kim HM, Mathew S, Tilz R, et al. Multicenter outcomes for catheter ablation of idiopathic premature ventricular complexes. J Am Coll Cardiol EP 2015; 1: 116 - 123
Kumagai K. Idiopathic ventricular arrhythmias arising from the left ventricular outflow tract: Tips and tricks. J Arrythmia 2014; 30: 211 - 221

Responsible Party: Mohamed Abo Elhassan Abdel_Rady, M. abo Elhassan, Assiut University
ClinicalTrials.gov Identifier: NCT03258112     History of Changes
Other Study ID Numbers: electrophysiology
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No